Obstructive Sleep Apnea SyndromeNTDNCT01601509
Nasal Tramazoline and Dexamethazone in Obstructive Sleep Apnea (OSA) Patients Tramazoline and
A study testing Nasal tramazoline with dexamethazone in people with Obstructive Sleep Apnea Syndrome, run by University of Athens at 1 site in Greece.
Trial summary
Nasal resistance presents considerable variations during night[8]. Additionally, Oral and oro-nasal breathing epochs exhibit strong correlation with the number of apnoea/hypopnoeas [7].The hypothesis that the present study aims to test is whether the pharmacological prevention of increased nasal resistance during… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Nasal tramazoline with dexamethazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2010to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OSA patients (AHI > 10 events/h), and
- normal nasal resistance measured in seated and supine position with active anterior and posterior rhinomanometry (< 3.0 cmH20•L-1•s).
Who cannot join
- recent surgery involving the upper airways,
- central apnoeas more than three per hour or five percent of total apnoeas,
- total sleep time during polysomnographies less than three hours,
- current treatment with nasal decongestants and topical steroids, and
- upper or lower respiratory tract disease, including a history of nasal allergy, and
- smoking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Placebo-controlled Cross-over Trial of the Effect of Nasal Tramazoline With Dexamethasone in Obstructive Sleep Apnoea Patients
Nasal resistance presents considerable variations during night[8]. Additionally, Oral and oro-nasal breathing epochs exhibit strong correlation with the number of apnoea/hypopnoeas [7].The hypothesis that the present study aims to test is whether the pharmacological prevention of increased nasal resistance during night could alter breathing route pattern and lead to a decrease in the number of apnoea/hypopnoeas in OSA patients with normal nasal resistance.
Read the detailed description
Nasal obstruction impairs sleep quality and may predispose to snoring and obstructive sleep apnoea (OSA) [1]. Indeed, in healthy subjects, experimental nasal occlusion has been shown to elicit obstructive apnoeas [2]. Additionally, in patients with OSA nasal obstruction is considered a risk factor for the development of OSA [3].
Despite the relationship between nasal obstruction and OSA, the therapeutic effect of improving nasal airway patency on OSA severity remains a point of conjecture [4]. In fact, administration of intranasal corticosteroids has been shown to improve sleepiness and reduce the apnoea/hypopnoea index (AHI) in patients with OSA and rhinitis [5], whereas in OSA patients with nasal obstruction the use of topical decongestants, external nasal dilators and nasal surgery has provided equivocal results [6].
The present authors have demonstrated a strong correlation between apnoea-hypopnoea index and oral/oro-nasal breathing epochs in patients with OSA and normal nasal resistance [7]. Additionally, Kohler et al [8] have shown that nasal resistance may increase during sleep reflecting substantial variability. Therefore, it is plausible to hypothesize that OSA patients presenting with normal nasal resistance when they are awake may demonstrate increased nocturnal nasal resistance during sleep that may predispose to oral/oro-nasal breathing and elicit apnoea/hypopnoeas. Prevention of nocturnal nasal obstruction in such OSA patients may decrease oral/oro-nasal breathing and eventually be beneficial for OSA by decreasing apnoea/hypopnoeas. Thus, the present study aims to investigate whether the pharmacological prevention of nasal obstruction could alter breathing route pattern and lead to a decrease in the number of apnoea/hypopnoeas in OSA patients with normal nasal resistance.
The study will include two nasal treatment options. Firstly, a combination of a nasal decongestant (tramazoline) with a nasal corticosteroid (dexamethazone). Tramazoline (imidazoline derivative) is a nasal decongestant, which attains its maximal effect between 30 and 210 min after application [9], while nasal dexamethasone can attenuate nasal inflammation associated with OSA [10]. Secondly, sodium chloride (0.9% solution).
OSA patients (AHI>10 events/h) with normal nasal resistance measured in seated and supine position with active anterior and posterior rhinomanometry (<3.0 cmH20•L-1•s) will be recruited. Exclusion criteria will be considered: 1) recent surgery involving the upper airways, 2) central apnoeas more than three per hour or five percent of total apnoeas, 3) total sleep time during polysomnographies less than three hours, 4) current treatment with nasal decongestants and topical steroids, and 5) upper or lower respiratory tract disease, including a history of nasal allergy, and 6) smoking.
A randomized double-blind, placebo-controlled, cross-over design will be used (Figure 1). Every patient will undergo four assessments which will take place 24-48 hours after each treatment arm. Every assessment will consist of an overnight polysomnography with concomitant measurement of breathing route pattern (oral, nasal, oro-nasal breathing epochs) as previously described [7], along with a nasal resistance measurement. After baseline assessment and randomization patients of the first group will undergo a one-week therapy with nasal tramazoline and dexamethazone, while the patients of the second group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution). The second assessment will take place at the end of this one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next the patients of the first group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution), while the patients of the second group will undergo a one-week therapy with nasal tramazoline and dexamethazone. Fourth assessment will then follow.
Figure 1. Study design
First group: one First group: one week nasal week nasal placebo tramazoline with dexamethazone
2 weeks washout period
Second group: one Second group: one week nasal placebo week nasaltramazoline with dexamethazone
First Assessment Second Assessment Third Assessment Fourth Assessment
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Nasal tramazoline with dexamethazone, Nasal placebo
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal tramazoline with dexamethazoneDrug
Every patient will undergo four assessments. Every assessment will consist of an overnight polysomnography with concomitant measurement of breathing route pattern (oral, nasal, oro-nasal breathing epochs) as previously described [7], along with a nasal resistance measurement. After baseline assessment and randomization patients of the first group will undergo a one-week therapy with nasal tramazoline and dexamethazone, while the patients of the second group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution). The second assessment will take place at the end of this one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next the patients of the first group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution), while the patients of the second group will undergo a one-week therapy with nasal tramazoline and dexamethazone. Fourth assessment will then follow.
Nasal placeboDrug
Every patient will undergo four assessments. Every assessment will consist of an overnight polysomnography with concomitant measurement of breathing route pattern (oral, nasal, oro-nasal breathing epochs) as previously described [7], along with a nasal resistance measurement. After baseline assessment and randomization patients of the first group will undergo a one-week therapy with nasal tramazoline and dexamethazone, while the patients of the second group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution). The second assessment will take place at the end of this one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next the patients of the first group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution), while the patients of the second group will undergo a one-week therapy with nasal tramazoline and dexamethazone. Fourth assessment will then follow.
| Study group | Role | What they receive |
|---|---|---|
| nasal spray with tramazoline and dexamethazone | Active comparator | Not described Receives: Drug: Nasal tramazoline with dexamethazone |
| Placebo | Placebo comparator | Not described Receives: Drug: Nasal placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnoea-hypopnoea index
After baseline assessment and randomization first group will undergo a one-week therapy with nasal tramazoline-dexamethazone, while second group will undergo a one-week therapy with nasal placebo. The second assessment will take place at the end of one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next first group will undergo a one-week therapy with nasal placebo, while second group will undergo a one-week therapy with nasal tramazoline-dexamethazone. Fourth assessment will then follow.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startApr 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Koutsourelakis, University of Athens
- Investigators
- Ioannis Koutsourelakis, MD, Principal investigator, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601509
- Sponsor's protocol ID
- UOA-123
- Acronym
- NTD
- Status last verified
- May 2012
- First submitted
- 4 Mar 2012
- Last updated
- 18 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Koutsourelakis I, Minaritzoglou A, Zakynthinos G, Vagiakis E, Zakynthinos S. The effect of nasal tramazoline with dexamethasone in obstructive sleep apnoea patients. Eur Respir J. 2013 Oct;42(4):1055-63. doi: 10.1183/09031936.00142312. Epub 2013 Feb 8.
PubMed 23397296
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Cross-over Trial of the Effect of Nasal Tramazoline With Dexamethasone in Obstructive Sleep Apnoea Patients
- ClinicalTrials.gov ID
- NCT01601509
- Acronym / sponsor ID
- NTD / UOA-123
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nasal resistance presents considerable variations during night[8]. Additionally, Oral and oro-nasal breathing epochs exhibit strong correlation with the number of apnoea/hypopnoeas [7].The hypothesis that the present study aims to test is whether the pharmacological prevention of increased nasal resistance during night could alter breathing route pattern and lead to a decrease in the number of apnoea/hypopnoeas in OSA patients with normal nasal resistance.
Detailed description
Nasal obstruction impairs sleep quality and may predispose to snoring and obstructive sleep apnoea (OSA) [1]. Indeed, in healthy subjects, experimental nasal occlusion has been shown to elicit obstructive apnoeas [2]. Additionally, in patients with OSA nasal obstruction is considered a risk factor for the development of OSA [3].
Despite the relationship between nasal obstruction and OSA, the therapeutic effect of improving nasal airway patency on OSA severity remains a point of conjecture [4]. In fact, administration of intranasal corticosteroids has been shown to improve sleepiness and reduce the apnoea/hypopnoea index (AHI) in patients with OSA and rhinitis [5], whereas in OSA patients with nasal obstruction the use of topical decongestants, external nasal dilators and nasal surgery has provided equivocal results [6].
The present authors have demonstrated a strong correlation between apnoea-hypopnoea index and oral/oro-nasal breathing epochs in patients with OSA and normal nasal resistance [7]. Additionally, Kohler et al [8] have shown that nasal resistance may increase during sleep reflecting substantial variability. Therefore, it is plausible to hypothesize that OSA patients presenting with normal nasal resistance when they are awake may demonstrate increased nocturnal nasal resistance during sleep that may predispose to oral/oro-nasal breathing and elicit apnoea/hypopnoeas. Prevention of nocturnal nasal obstruction in such OSA patients may decrease oral/oro-nasal breathing and eventually be beneficial for OSA by decreasing apnoea/hypopnoeas. Thus, the present study aims to investigate whether the pharmacological prevention of nasal obstruction could alter breathing route pattern and lead to a decrease in the number of apnoea/hypopnoeas in OSA patients with normal nasal resistance.
The study will include two nasal treatment options. Firstly, a combination of a nasal decongestant (tramazoline) with a nasal corticosteroid (dexamethazone). Tramazoline (imidazoline derivative) is a nasal decongestant, which attains its maximal effect between 30 and 210 min after application [9], while nasal dexamethasone can attenuate nasal inflammation associated with OSA [10]. Secondly, sodium chloride (0.9% solution).
OSA patients (AHI>10 events/h) with normal nasal resistance measured in seated and supine position with active anterior and posterior rhinomanometry (<3.0 cmH20•L-1•s) will be recruited. Exclusion criteria will be considered: 1) recent surgery involving the upper airways, 2) central apnoeas more than three per hour or five percent of total apnoeas, 3) total sleep time during polysomnographies less than three hours, 4) current treatment with nasal decongestants and topical steroids, and 5) upper or lower respiratory tract disease, including a history of nasal allergy, and 6) smoking.
A randomized double-blind, placebo-controlled, cross-over design will be used (Figure 1). Every patient will undergo four assessments which will take place 24-48 hours after each treatment arm. Every assessment will consist of an overnight polysomnography with concomitant measurement of breathing route pattern (oral, nasal, oro-nasal breathing epochs) as previously described [7], along with a nasal resistance measurement. After baseline assessment and randomization patients of the first group will undergo a one-week therapy with nasal tramazoline and dexamethazone, while the patients of the second group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution). The second assessment will take place at the end of this one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next the patients of the first group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution), while the patients of the second group will undergo a one-week therapy with nasal tramazoline and dexamethazone. Fourth assessment will then follow.
Figure 1. Study design
First group: one First group: one week nasal week nasal placebo tramazoline with dexamethazone
2 weeks washout period
Second group: one Second group: one week nasal placebo week nasaltramazoline with dexamethazone
First Assessment Second Assessment Third Assessment Fourth Assessment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal spray with tramazoline and dexamethazone | Active comparator | Drug: Nasal tramazoline with dexamethazone |
| Placebo | Placebo comparator | Drug: Nasal placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- OSA patients (AHI > 10 events/h), and
- normal nasal resistance measured in seated and supine position with active anterior and posterior rhinomanometry (< 3.0 cmH20•L-1•s).
Key exclusion criteria (6 listed)
- recent surgery involving the upper airways,
- central apnoeas more than three per hour or five percent of total apnoeas,
- total sleep time during polysomnographies less than three hours,
- current treatment with nasal decongestants and topical steroids, and
- upper or lower respiratory tract disease, including a history of nasal allergy, and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal tramazoline with dexamethazoneEvery patient will undergo four assessments. Every assessment will consist of an overnight polysomnography with concomitant measurement of breathing route pattern (oral, nasal, oro-nasal breathing epochs) as previously described [7], along with a nasal resistance measurement. After baseline assessment and randomization patients of the first group will undergo a one-week therapy with nasal tramazoline and dexamethazone, while the patients of the second group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution). The second assessment will take place at the end of this one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next the patients of the first group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution), while the patients of the second group will undergo a one-week therapy with nasal tramazoline and dexamethazone. Fourth assessment will then follow. | Drug | nasal spray with tramazoline and dexamethazone |
| Nasal placeboEvery patient will undergo four assessments. Every assessment will consist of an overnight polysomnography with concomitant measurement of breathing route pattern (oral, nasal, oro-nasal breathing epochs) as previously described [7], along with a nasal resistance measurement. After baseline assessment and randomization patients of the first group will undergo a one-week therapy with nasal tramazoline and dexamethazone, while the patients of the second group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution). The second assessment will take place at the end of this one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next the patients of the first group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution), while the patients of the second group will undergo a one-week therapy with nasal tramazoline and dexamethazone. Fourth assessment will then follow. | Drug | Placebo |
Primary outcome
Apnoea-hypopnoea index
Time frame: up to 4 weeks
After baseline assessment and randomization first group will undergo a one-week therapy with nasal tramazoline-dexamethazone, while second group will undergo a one-week therapy with nasal placebo. The second assessment will take place at the end of one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next first group will undergo a one-week therapy with nasal placebo, while second group will undergo a one-week therapy with nasal tramazoline-dexamethazone. Fourth assessment will then follow.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
- Derived from this study: PubMed 23397296Koutsourelakis I, Minaritzoglou A, Zakynthinos G, Vagiakis E, Zakynthinos S. The effect of nasal tramazoline with dexamethasone in obstructive sleep apnoea patients. Eur Respir J. 2013 Oct;42(4):1055-63. doi: 10.1183/09031936.00142312. Epub 2013 Feb 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis Koutsourelakis, MD principal investigator
University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal tramazoline with dexamethazone in people with Obstructive Sleep Apnea Syndrome, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnoea-hypopnoea index (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01601509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2012.